# K014268: Norapad Plain; Norapad TA

- Pathway: 510(k) (Traditional)
- Applicant: Perlei Medical, Inc.
- Decided: Mar 27, 2002 after 90 days
- Product code: HBA (Neurosurgical Paddie)
- Device class: 2
- Regulation: 21 CFR 882.4700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K993019 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993019: Pacific Surgical Patties, V. Mueller Neuro/Spine (2000) Summary page 1.

## Indications for use
Intended for neurosurgical procedures to protect tissue, absorb fluids and stop bleeding. They are Supplied to the uscr in sterile packages. These patties are X-ray detectable and are provided in 2 Variety of sizes necessary to meet clinical needs.

Source page: https://510kreport.com/device/K014268
Methodology: https://510kreport.com/methodology